A Study to Assess the Effectiveness of the Nautilus BrainPulse™ as an Aid in the Diagnosis of Concussion



Status:Recruiting
Conditions:Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:10 - 25
Updated:9/22/2018
Start Date:November 2015
End Date:April 2019
Contact:Prabhu Raghavan
Email:praghavan@janmedical.com
Phone:1-650-567-4611

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The objective of the study is to evaluate, in a blinded fashion, the effectiveness of the
Nautilus BrainPulse device when used as an aid in the diagnosis of concussion.

This is a prospective, non-randomized, blinded, matched control study of young athletes (ages
10-25 years old) in competitive sports (Cohort A: higher-risk of concussion, Cohort B:
lower-risk of concussion) to assess the effectiveness of the Nautilus BrainPulse device when
used as an aid in the diagnosis of concussion.

The Nautilus BrainPulse is intended for use on a patient's head to non-invasively detect,
amplify and capture the brain pulse, the brain motion caused by pulsatile blood flow from the
cardiac cycle. The Nautilus BrainPulse analyzes the captured data to provide an aid in
diagnosing an episode of concussion.

Inclusion Criteria:

1. Male or female subjects between 10 and 25 years of age (middle school, high school or
college-age)

2. Team member, where the team meets at least twice a week

3. Willing and able to participate in all study evaluations and allow access to medical
testing and records

4. Signed informed consent, or have a legally authorized representative willing to
provide informed consent on behalf of the subject if the subject is a minor

Exclusion Criteria:

1. Documented history of a concussion diagnosed by a physician in the last two months
assessed via interview with athlete

2. Known history of any cognitive deficits that diminish ability to administer study
assessments, such as SCAT3™

3. Wound on the head in the area of one of the Nautilus BrainPulse sensors that would
impede use of the Nautilus BrainPulse device

4. Inability to obtain a valid SCAT3 and ImPACT® baseline assessment of concussion

5. Any serious medical, social or psychological condition that in the opinion of the
investigator would impair ability to provide informed consent or otherwise disqualify
a patient from participation
We found this trial at
3
sites
Fort Lauderdale, Florida 33308
Principal Investigator: Gayan Poovendran, MD
Phone: 786-423-1383
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Baton Rouge, Louisiana 70803
Principal Investigator: Ralph Castle, PhD, ATC
Phone: 225-578-3894
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Baton Rouge, LA
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Munster, Indiana 46321
Principal Investigator: Victoria Perez, ATC
Phone: 574-329-2386
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Munster, IN
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